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An Israeli company has been granted clearance from the US Food and Drug Administration (FDA) for its software used in the removal of liver tumors.
The BioTracelO software created by Rehovot-based TechsoMed (opens in a new tab) Medical Technologies received De Novo clearance from the FDA, which is approval granted to a novel system.
The software is used during ablation therapy – a minimally invasive treatment that uses extreme temperatures to kill tumors – and is designed to predict the tissue response to the therapy.
It is also designed to aid physicians who are performing liver tumor removal by providing real-time visuals with the ultrasound imaging.
TechsoMed Founder and CEO Yossi Abu and Chief Strategy Officer Eran Naveh are Technion alumni.